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510(k) K834396

DIRECT IRON REAGENT SET by Seragen Diagnostics, Inc. — Product Code CFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1984
Date Received
December 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bathophenanthroline, Colorimetry, Iron (Non-Heme)
Device Class
Class I
Regulation Number
862.1410
Review Panel
CH
Submission Type

Other clearances by Seragen Diagnostics, Inc.

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  • K851663 — QUICK-COUNT HEMATOLOGY CONTROLS (July 23, 1985)
  • K852260 — QUICK-CHEM CALIBRATION SET (July 22, 1985)
  • K851520 — CK/LD ISOENZYMES CONTROLS(HUMAN) (June 25, 1985)
  • K851521 — LD-1(IMMUNO) SEPARATION SET (May 10, 1985)
  • K850209 — QUICK-LYTE (February 27, 1985)
  • K844743 — SERATEST ENA(RNP/SM) DETERMINATION (February 4, 1985)
  • K842563 — SERATEST DNA DETERMINATION (October 25, 1984)
  • K841504 — QUICK-COUNT PLUS 2 (June 11, 1984)
  • K840793 — CK/MB IMMUNO-ISOENZYME CONTROL SERUM (April 13, 1984)

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  • K913705 — ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 (October 9, 1991)
  • K912912 — SYNERMED SERUM IRON-600 REAGENT KIT (July 30, 1991)
  • K902918 — SYNERMED SERUM IRON REAGENT KIT (July 31, 1990)
  • K895047 — CLINISTAT POTASSIUM REAGENT TEST (October 17, 1989)
  • K891155 — IRON REAGENT (April 18, 1989)
  • K873120 — ABBOTT A-GENT IRON REAGENT KIT (August 25, 1987)
  • K861602 — TOTAL IRON BINDING CAPACITY PROCEDURE (May 23, 1986)